Emergent Supplies 1M BioThrax Doses While HHS Reworks Plans

The strategic national stockpile has received nearly another million anthrax vaccine doses by way of an early delivery from Emergent BioSolutions Inc., a company clearly positioning itself to further fulfill the government's needs going forward.

The biopharmaceutical firm, of Rockville, Md., now has provided 10 million doses to the nation's supply. Its product, BioThrax (anthrax vaccine adsorbed, or AVA), is the only FDA-approved anthrax vaccine. It was first licensed in 1970.

"We manufacture BioThrax 24 hours a day, seven days a week," said Robert Burrows, Emergent's vice president of corporate communications. "It's about efficiencies, and this is what we do. We're the only producer, and we're ready to provide product when and where necessary."

Emergent received $22 million for this delivery, and Burrows told BioWorld Today that the company is "absolutely" working to sell more to the Department of Health and Human Services (HHS), which is coordinating procurement efforts for the stockpile in the event of another civilian attack with anthrax. The company has supplied BioThrax through two 5 million-dose orders from the department, which is buying it for off-label, postexposure use under an emergency use authorization.

Over the past couple of years, HHS had been aiming to acquire a previously stated, top-end goal of 75 million total anthrax vaccine doses, but now is backing off that projection and instead is reworking plans on how much to accumulate.

"The number of doses that we will buy for the stockpile is currently under review," spokesman Marc Wolfson told BioWorld Today, noting that HHS officials "are still looking at that whole process and how many doses they're going to buy at this point."

The bulk was expected to be in the form of a so-called second-generation product, for which Brisbane, Calif.-based VaxGen Inc. had received an $877.5 million order more than two years ago for its recombinant protective antigen (rPA) vaccine. But at the end of last year, HHS dissolved that arrangement following stability setbacks with the product. (See BioWorld Today, Dec. 21, 2006.)

And while Wolfson said the department "is still committed to procuring a second-generation" vaccine, HHS has yet to issue any official orders for another anthrax vaccine of any sort. "Ultimately this is all going to be revealed," he said, "but they're not ready to announce it yet."

Burrows said Emergent's work to improve BioThrax could fulfill the department's desire for a second-generation product, one with a better profile in terms of a shorter course of treatment. At present, the vaccine is delivered through three initial doses within four weeks, followed by three additional administrations at six, 12 and 18 months. In collaboration with the Centers for Disease Control and Prevention, the company is developing a newer version that cuts the number of doses in half and has a three-year shelf life.

"We're not resting on our laurels," Burrows said. "We're continuing to progress and enhance BioThrax to become a better product than it already is."

Another company developing a second-generation anthrax vaccine, Avecia Biotechnology Inc., of Milford, Mass., is working on the rPA route.

Both companies were among several caught by surprise last week when HHS canceled a request for bids to produce a third-generation anthrax vaccine, a process that was being run by the National Institute of Allergy and Infectious Diseases. Wolfson, who said the decision followed a peer-reviewed procedure, added that NIAID isn't walking away from its goal, but instead is conceding that none of the current proposals was the right fit.

"The proposed candidates weren't sufficiently mature to meet the milestones that were required," he said, "so they decided it would be premature to make an award at this time because it could actually undermine long-term efforts to obtain a third-generation vaccine."Such a product was expected to have enhanced characteristics with room temperature storage and an extended shelf life, and make use of new adjuvants and delivery systems, essentially providing a tool for mass immunization. Emergent's efforts in that area make use of an adjuvant from Coley Pharmaceutical Group Inc., of Wellesley, Mass., and their partnered work is moving forward.

"If HHS remains committed to some next-generation [anthrax vaccine], or equivalent thereof," Burrows said, "we're confident that the product we currently have as well as its enhanced version will have a very good potential to be a participant in whatever procurement contract comes from that."

The company, which was previously known as BioPort Corp., also sells BioThrax to the Department of Defense for military use. The Pentagon has bought more than 8 million doses to date, and is committed to purchase another 11 million doses in the next five years. In addition, Burrows said the Defense Department's plan to resume mandatory vaccinations in certain high-threat areas represent "a nice opportunity" to supply more BioThrax.

The company also is looking to expand the product's market internationally to include friendly governments, as well as for first-response use within domestic local governments. In addition, the company is working to expand BioThrax's label to include postexposure prophylaxis when used in conjunction with antibiotics.

Beyond anthrax vaccines, HHS also has contracted to purchase anthrax therapeutics for the stockpile. Rockville-based Human Genome Sciences Inc. has an order for 20,000 treatment courses of its monoclonal antibody ABthrax, and Cangene Corp., of Winnipeg, Manitoba, is to produce 10,000 doses of anthrax immune globulin.

There is speculation that HHS' continued silence on plans for further vaccine procurements is a signal that more therapeutic contracts are on tap - certainly a number of companies are waiting in the wings - but Wolfson said such talk remains conjecture ahead of HHS' intention to unveil a broad implementation plan that will include public guidance on various biological, chemical and radiological threats. It could be released just before a stakeholders' meeting being scheduled for the middle of the year.

"When it's laid out there," he said, "you'll see exactly what they're going to be looking for in terms of therapeutics, vaccines and all the other stuff they're going to buy."

In addition to BioThrax, Emergent is developing a few other biodefense products: an anthrax immune globulin, a botulinum vaccine and a botulinum immune globulin. On Friday, its stock (NYSE:EBS) traded down 4 cents to close at $14.02, following a sharper drop earlier in the week after the third-generation anthrax vaccine news broke.

Mandatory Anthrax Shots to Resume in March

Mandatory anthrax vaccinations for servicemembers in South Korea could begin in late March, a U.S. Forces Korea spokesman said Friday.Over the next few weeks, USFK will review the plans submitted from each military branch that define how the shots will be distributed, spokesman David Oten said.

So far, USFK estimates the vaccine distribution will begin in late March, he said.The vaccine is required as well for Department of Defense essential civilians and contractors in South Korea and in the U.S. Central Command.

Earlier this month, the Pentagon’s top health official approved plans to resume the mandatory vaccine for troops in South Korea and in the Central Command theater.

Six Department of Defense workers are fighting the requirement. Their lawyer said last week he plans to seek a temporary restraining order on the latest decision.

In October 2004, a U.S. District Court judge barred defense officials from administering the mandatory inoculations, citing mistakes in how the Food and Drug Administration determined the vaccine’s safety.

Six months later, he loosened that ban, saying the vaccines could resume on an “emergency use” voluntary basis.

Since then, the vaccinations — six shots given over 18 months — have been given on a voluntary basis. But only about half of U.S. troops opted to get the shots, prompting the Defense Department to announce in 2006 they would be mandatory for troops deemed most at risk.

The Defense Department administered more than 5.2 million vaccine doses to more than 1.3 million military personnel between 1998 and October 2004.

At Misawa Air Base in northern Japan , the mandatory anthrax vaccination program will resume on March 19, as per Air Force directive, said Lt. Col. Kevin Connolly, 35th Aerospace Medical Squadron commander.

Active-duty personnel deploying for 15 or more consecutive days to the U.S. Central Command area of operation or the Korean peninsula will be required to get the shot within 60 days of departure.

The same policy applies to Defense Department civilian employees deemed “emergency essential” or the equivalent, as well as government contractors carrying out “mission-essential” services.

However, for the latter personnel, the contract must specify the immunization as a requirement, Connolly said.

Medical and administrative exemptions will apply in some cases, Connolly said.Groups that can receive the vaccine on a voluntary basis include:U.S. government civilian employees and contractors assigned to the same areas for the same period of time, who don’t fall under the mandatory policy.Adult family members, ages 18 to 65, accompanying DOD military and civilian personnel for 15 or more consecutive days to CENTCOM or Korea .Adult family members who are ages 18 to 65 and U.S. citizens, who are accompanying U.S. contractors to the same areas for 15 or more consecutive days.Connolly said Misawa will have enough vaccine to resume anthrax immunizations starting March 19. “We’ve ordered more to ensure we have enough on supply,” he said.

Of the airmen from Misawa currently deployed to Iraq and throughout Central Command, Connolly said, “they will get the vaccine in the AOR.”

February 23, 2007

Emergent Sinks As Government Ends Deal

NEW YORK — Shares of biopharmaceutical company Emergent BioSolutions Inc. tumbled Thursday after the U.S. government canceled a request for an anthrax vaccine.

Emergent said that due to "programmatic considerations" the National Institute of Allergy and Infectious Disease is no longer seeking a request for proposal notice for a third generation anthrax vaccine.

JPMorgan analyst Dr. Richard Smith said in a client note that the bad news will hurt Emergent, as well as other companies that were seeking similar contracts, but did not expect the canceled request to have much impact on the stock. He reiterated his "Overweight" rating for Emergent shares.

"The largest near-term driver for Emergent continues to be securing of a 11 million dose contract from the Department of Defense for BioThrax as well as further orders from Health and Human Services," he said. BioThrax is a first generation anthrax vaccine.

Emergent shares dropped $1.47, or nearly 10 percent, to $13.56 in midday trading on the New York Stock Exchange. The stock _ which closed at $15.03 on Wednesday _ is down 15.3 percent since hitting an all-time high of $17.75 on Jan. 25. Emergent began trading on Nov. 15.

Bush to nominate new defense official for health

Feb 22, 2007 — WASHINGTON (Reuters) - President George W. Bush plans to replace the assistant defense secretary for health affairs, the White House said on Thursday, two days after a review was ordered into outpatient care for wounded troops.

The Pentagon said William Winkenwerder had planned to leave his post since last year and the announcement was not related to problems at the military's flagship Walter Reed Army Medical Center in Washington, highlighted in recent press reports.

Casscells now serves as medicine and public health professor at the University of Texas Health Science Center at Houston.

The nomination is subject to U.S. Senate confirmation.

The Bush administration ordered a review on Tuesday of the care of troops wounded in Iraq and Afghanistan after The Washington Post reported that outpatients at Walter Reed were living in shoddy conditions and being neglected by officials.

The Pentagon’s top health official has approved each service’s plans to resume mandatory anthrax vaccinations for troops on the Korean peninsula and in the U.S. Central Command theater of operations, said Defense Department spokeswoman Cynthia Smith.

It is now up to each service to determine when to resume the mandatory anthrax program, Smith said Thursday.

The vaccinations had been given on a voluntary basis since January 2005, but only about half of U.S. troops opted to get the shots, prompting the Defense Department to announce in 2006 that they would be mandatory for troops deemed most at risk.

But Washington, D.C., lawyer Mark Zaid has vowed to take legal action to prevent the Defense Department from resuming mandatory shots.

Zaid, who represents six Defense Department employees who refused to take the vaccine, plans to file a temporary restraining order in the next two to three weeks, if not sooner, he said in a Thursday e-mail to Stars and Stripes.

Smith declined to say how such a move would affect the Defense Department’s plans to make anthrax vaccinations for some troops mandatory again.

“We aren’t going to comment on litigation that hasn’t even been filed,” she said in a Thursday e-mail to Stars and Stripes.

Meanwhile, the Air Force plans to resume its mandatory anthrax vaccination program for some airmen in about three weeks, said Air Force spokeswoman Brenda Campbell on Thursday.

The Air Force has sent its implantation plans to all major commands so that each unit can prepare to vaccinate airmen who rotate to the Korean peninsula and the CENTCOM area of operations, Campbell said.

Army Col. Randall Anderson, director of the Military Vaccine Agency did not give a time line of when soldiers would begin receiving mandatory anthrax vaccinations, saying units and clinics were working to meet each service’s plans for mandatory anthrax vaccinations.

“The resumption of the mandatory vaccines will begin when the requirements of each plan are completed by a unit or clinic, mandatory vaccinations for those covered by the policy may begin,” Anderson said in an e-mailed response to questions Thursday. “It could have begun in some places.”

The Navy could not be reached for comment by deadline on when sailors and Marines will start receiving mandatory anthrax vaccinations.

The bill, introduced in the House this week, is an attempt to address the lagging pace of Project BioShield, a federal effort that has delivered little since it was launched nearly three years ago.

Designed to create an incentive for private enterprise to develop biological countermeasures to unconventional weapons, BioShield dangles cash in front of biotech firms but gives no money until a product is delivered.

Officials at the helm of the $5.6 million program have spent less than 25 percent of their budget, and late last year the Health and Human Services Department abandoned a $1 bullion contract with a California company to provide 75 million doses of an anthrax vaccine (see GSN, Dec. 20, 2006).

President George W. Bush announced the BioShield program during his State of the Union address in 2004, indicating the initiative would counter threats such as the plague and Ebola. To date, however, the program has done little to address these potential biological agents.

BioShield’s limited progress has attracted the attention of representatives on the House Homeland Security Committee who have highlighted the program as a focus for oversight and hearings this year.

“I’d just say I’m very concerned with some of the recent problems that have come to light with respect to the BioShield project,” Representative James Langevin (D-R.I.) said earlier this month. “For example, we all recently heard about the cancellation of VaxGen’s contract for a next generation anthrax vaccine and, at the time, this was the only major procurement contract under BioShield.”

Langevin, chairman of the homeland security subcommittee covering emerging threats, is a cosponsor of the new legislation.

Under the current program, the Homeland Security Department first identifies and assesses threats and countermeasures. Once that is completed, the Health and Human Services Department then selects firms to develop specific countermeasures.

The recently introduced bill is designed to accelerate the threat-assessment process. To the extent possible, the Homeland Security Department will be required to clump possible countermeasures into groups that might be able to address more than one chemical, biological or radiological agent.

“Rather than examining each threat individually, we should be looking for ways to properly group these threats together,” Langevin said this week. “This legislation will promote a more strategic use of our nation’s resources when procuring medical countermeasures.”The bill would also require that homeland security assessments of the most high-risk agents be completed by the end of 2007.

“Effective medical countermeasures for chemical, biological, radiological and nuclear agents are a critical part of our nation’s defense against terrorism, yet very few exist,” said Representative Mike McCaul (R-Texas), a member of the homeland security subcommittee for emerging threats

Company (Bioport/Emergent) Acknowledges NIAID Has Cancelled Solicitation for Bids for Development of a Third Generation Anthrax Vaccine

Emergent BioSolutions Remains Committed to Development of Enhanced Anthrax Countermeasures Company Acknowledges NIAID Has Cancelled Solicitation for Bids for Development of a Third Generation Anthrax Vaccine ROCKVILLE, Md.--(BUSINESS WIRE)--

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has been informed by the National Institute of Allergy and Infectious Diseases (NIAID) that NIAID has cancelled its solicitation for bids that it sought under a request for proposals, RFP NIH-NIAID-DMID- 07-05 “Development of a Third Generation Anthrax Vaccine,” due to “programmatic considerations.” The company was one of the respondents to this RFP, which NIAID issued in June 2006.

“Emergent BioSolutions remains committed to developing biodefense countermeasures, including anthrax vaccines and immune globulins,” said Fuad El-Hibri, chairman and chief executive officer. “This cancellation from NIAID does not diminish that commitment. We expect to continue to pursue one or more of the enhancements sought under the RFP, such as room temperature storage, extended shelf life, novel adjuvants and novel delivery systems.”

Since 1998, the company has delivered over 18 million doses of BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Government in support of the military’s immunization program and the country’s strategic national stockpile effort. The Centers for Disease Control and Prevention (CDC) is currently conducting a multi-year study, commenced in 2002, designed to enhance the current anthrax vaccine by reducing the dose regimen, introducing a second route of administration and extending the booster regimen to potentially three years. The company is also working on expanding the label indication for BioThrax to include its use as a post-exposure prophylaxis. Additional BioThrax enhancement initiatives include dating extension beyond three years and stability studies for room temperature storage.

Continuing, Mr. El-Hibri stated, “Based on the recent Homeland Security Presidential Directive HSPD-18 regarding medical countermeasures against weapons of mass destruction, we believe the U.S. Government remains committed to building a robust biodefense industry in support of protecting the public against Class A bioterror agents, including anthrax, which the U.S. Government has indicated is a top priority. As the manufacturer of the only FDA licensed vaccine for the prevention of anthrax infection, we look forward to continuing to work together with the U.S. Government for the nation’s benefit.”

In addition to BioThrax, the company remains focused on developing its broad product portfolio including an anthrax immune globulin, a botulinum vaccine and immune globulin as well as a typhoid vaccine and hepatitis B therapeutic vaccine, both in Phase II trials, a group B strep vaccine and a chlamydia vaccine. In addition, the company continues to develop a meningitis B vaccine in collaboration with Sanofi Pasteur.

About Emergent BioSolutions Inc. Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolu tions.com.

Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ongoing and future development efforts related to anthrax countermeasures, the impact of the NIAID RFP withdrawal, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain newBioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax®; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; andother factors identified in the company’s Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

NIH Decision to Shelve Third-Generation Anthrax Vaccine Seen as Setback for "Bioshield"

The National Institutes of Health has scrapped plans to develop a third-generation vaccine against anthrax, CQ Homeland Security has learned.

The decision, made several months after multiple bids were received, further complicates efforts to stockpile a vaccine against the biological weapon. A contract for a second-generation drug was cancelled last year.

The National Institute of Allergy and Infectious Diseases acknowledged its “programmatic decision to cancel” a request for proposal titled “Development of Third Generation Anthrax Vaccines.” Officials at NIAID, a division of NIH, had no further comment. Companies that had bid on the contract last summer were told of the cancellation late last week, according to sources.

Analysts said the decision is puzzling because it leaves the nation dependent on an outdated vaccine, with nothing in the pipeline.

“If you don’t have a next-generation vaccine and you don’t have a third-generation vaccine, it’s going to be very hard to come up with any future vaccines because these things develop in building block form,” said Robert Housman, a Democratic biodefense consultant.

Currently, the government has 9 million doses of the only approved anthrax vaccine, known as anthrax vaccine absorbed, or AVA, which is produced by Emergent Biosolutions.

The company is expected to deliver an additional million doses this year and also supplies the Pentagon with the drug.

The Department of Health and Human Services cancelled an $877.5 million deal with VaxGen Inc. in December to produce 75 million doses of second-generation vaccine, after the Brisbane, Calif, company missed a deadline for clinical trials because of stability issues with the drug.

HHS had said at the time it would move “swiftly” to seek a new second- generation anthrax contract, but has yet to issue a request for proposal.

The third-generation contract was considered eight to 10 years away from production, but HHS officials had been touting it in the wake of the VaxGen cancellation.

The contract was for three years, scheduled to begin this June.A spokesman for HHS was unavailable for comment.

The reason for the latest contract termination is unknown, but analysts suggested the entire anthrax vaccine procurement process might be retooled.

“We don’t know what their strategic plan is for anthrax,” Housman said. “The department has said they have developed a strategic plan for how they are going to move forward with new anthrax countermeasures. We don’t really know from this how this fits into that plan.”

It is the latest setback for Project BioShield (PL 108-276), which was created in 2004 to provide $5.6 billion over 10 years to create countermeasures to biological weapons and epidemics.

The second-generation vaccine was to be a recombinant protective antigen (rPA) vaccine. The rPA vaccine would come from a more highly defined product and be more consistent between production lots than the current Emergent vaccine, according to government officials. It also potentially would have less adverse effects and provide immunity with fewer doses than AVA.

Only one company is believed to be equipped to produce a second- generation rPA vaccine similar to VaxGen’s — Avecia Biologicals Ltd., a British company. It has received NIH funding since 2002 for vaccine development. But sources said it may have run into similar stability issues in clinical trials as VaxGen. An Avecia spokesman was unavailable for comment.

The third-generation drug would have, theoretically, allowed for fewer doses and had a longer shelf life. The NIAID RFP did not say whether it was to be an AVA or rPA vaccine.

Both Emergent and Avecia bid on the third-generation contract, sources said. Emergent made several bids, both for an augmented version of their current vaccine and one using rPA technology.

Envelopes laced with anthrax were mailed in 2001, killing five people and sickening 17 others. It led to the temporary shutdown of Congress and several U.S. Postal facilities.

Housman, who formerly represented VaxGen, said the decision to scrap plans to develop a third-generation vaccine would send a “chilling effect” to other companies considering entering the vaccine business.“

At a time when [Bioshield] is now under review . . . after it’s been subject to a fairly significant amount of criticism, to turn off the pipeline for anthrax is going to make industry pretty wary,” he said.

HHS has repeatedly asked Emergent for more doses of its drug. But the drug has been criticized by some in the military who were forced to take it, and the Food and Drug Administration has found 21 people died after receiving it, and more than 4,000 reported health problems.

The Defense Department recently resumed mandatory vaccinations, after the drug received full FDA approval.

Sen. Joseph I. Lieberman, I-Conn., chairman of the Homeland Security & Governmental Affairs Committee, said he will try to find out whether the government will be able to protect people from an anthrax attack.

“It is not surprising that NIH is cancelling plans to develop a third generation anthrax vaccine given the failure of the second generation vaccine. but I am disappointed NIH would cancel early research and development of a vaccine that is safe, can be taken in 1 or 2 doses, and can be administered quickly to a large number of people,” he said in an e-mail. “At my request, GAO is investigating what went wrong with the second generation vaccine, which should help clarify whether HHS is on the road to developing a vaccine that will protect the American people in the event of an anthrax attack.”

February 21, 2007

Editorial: Vaccine Policy at Issue (Anthrax)

Just as the Pentagon is set to resume mandatory anthrax shots for the troops, the vaccine's sole manufacturer, Emergent BioSolutions, says it is testing its product as a potential treatment after anthrax exposure.

In fact, the Food and Drug Administration has granted that project "fast track" status, a designation meant to expedite development and review of new drugs, and new uses for existing drugs, that are considered particularly important. The company reportedly is testing a regimen of three shots at two-week intervals, together with antibiotics, as a post-exposure anthrax treatment.

That raises an interesting issue: If the tests are successful and the FDA approves using the vaccine in that way, would the Pentagon be justified in forcing huge numbers of troops who are not infected to take the shots against their will?

Untold numbers of troops have suffered adverse reactions to this vaccine, many of them severe, some incapacitating.

If the drug proves effective as a post-exposure treatment and is approved for that use, it would seem unconscionable for the Pentagon to risk even one service member's health unnecessarily.

The vaccine and accompanying antibiotics could be used as the military uses nerve agent antidote, dispensing it to troops in high-threat regions with instructions to use it in the event of an attack.

By press time, the Pentagon had not responded to a request for comment on an issue that is, admittedly, still hypothetical.

But if the FDA certifies the anthrax vaccine as an effective post-exposure treatment, leaders in Congress should be locked and loaded to ask Defense Secretary Robert Gates and his top health official, William Winkenwerder Jr., pointed questions about the need to continue forcing huge numbers of healthy troops to roll up their sleeves and roll the dice on this vaccine.

In This Case, A Soldier Was Treated Beautifully at Walter Reed

So there's a website kerfuffle between National Review Online's Jonah Goldberg and Salon' s Glenn Greenwald about Dana Priest's Washington Post investigative reports which revealed conditions of dire neglect for injured and inform U.S. soldiers at Walter Reed Hospital. Goldberg said he doesn't particularly trust Priest's reporting and thinks her paper (and the New York Times) has an "agenda" -- presumably, making the Bush administration look bad.

NRO readers have written in to Goldberg, agreeing with him: saying Priest went out of her way to find an army hospital with "the crappiest conditions," etc.

But there was a case -- in 2000 -- in which Walter Reed Hospital went out of its way to give a catastrophically ill servicewoman -- a beautiful 27-year-old Navy lieutenant with a radiant smile and blazing red hair -- expensive, state-of-the-art care, including a round the clock private nurse. The young woman had acquired (right after receiving her fourth -- mandatory -- anthrax shot) a shockingly precipitous mystery disease, eventually diagnosed as a bizarrely speeded-up form of ametropic lateral sclerosis -- she lost in three months the amount of muscle function a middle aged ALS sufferer would lose in four years. During one of the rare moments that the round-the-clock nurse wasn't at her bedside, the patient whispered to a confidante the opinion she dared not reveal more widely: "The anthrax vaccine did this to me."

Flash back to the year 2000: There was a groundswell in the military, and among military doctors, against the mandatory status of the anthrax vaccine, which had been FDA-approved for experimental use only, but which every service man and woman had to take, under threat of court martial. One military doctor, Air Force captain John Buck, chose a court martial (and a $21,000 fine) rather than submit to the vaccine; he'd seen too many people get sick after taking the shot and felt the mandatory status for an experimental vaccine was a violation of servicepeople's rights. That documented number has since been shown to have increased. I spent five months investigating the vaccine's hitherto unreported disproportionate risk to women (a concern that was privately raised by the chief of the allergy-immunology department at Walter Reed at a private Pentagon conference of military doctors, the transcripts of which were leaked to me). There were a lot of stories of direly sick women that I could tell, in the pages of the magazine I was writing for, but one story I couldn't tell, because the sick young Navy lieutenant's mother was fearful that her round-the-clock care might be taken away if it was revealed that her daughter believed that the vaccine had made her sick. While I was researching the story, I received many phone calls from people who visited the sick young woman. These bedside visitors were: a former Army Top Gun (herself made seriously ill, probably by the vaccine); a Gulf War fighter pilot and Pentagon policy analyst; a Naval Reserve lieutenant colonel; and the ill young woman's mother's best friend. All of these four sources told me that they thought the family was gratefully accepting this level of care for her...essentially in return for keeping quiet. A daily visitor to the young woman's bedside was the wife of government official who had a lot to do with military medical research. The official's wife became a close friend of the young woman's mother -- she was at the patient's bedside almost every day. Now of course, the friendship may have been completely sincere and coincidental -- no one knows otherwise.

When the young woman died, no one at her funeral (which I attended) talked of her belief that the vaccine had made her sick. No one mentioned that people close to her strongly believed that the level of extraordinary medical care and the personal attention of official's wife at Walter Reed might have been a subtle quid pro quo for her keeping quiet about her fear about the source of her terminal illness. In her private room at Walter Reed, on her oscillating bed, tracheotomy and ventilator, she was as vulnerable as a human being can be -- she had to be suctioned every few minutes or else she could suffocate on her own mucuous and spittle; how on earth could she afford to say anything bad about the military? And how could her grieving mother? So they said nothing, and she received wonderful care. And then she was dead.

So that's an excellent-care-at-Walter Reed Hospital story that went untold. Ironic, in terms of it, that the issue of care at Walter Reed and politics and saying good things or bad things about military health care for political reasons should come up now --- the anthrax vaccine (after being not mandatory to our fighting men and women for years) has, just last week, been made mandatory again.

February 20, 2007

Editorial: Can a Safe Vaccine be Made Using Current Strategies? Maybe not.

Can a safe anthrax vaccine be made using current strategies? Maybe Not.By Dr. Meryl Nass

VaxGen's contract with HHS for 75 million doses of a new, purer anthrax vaccine went up in smoke in December '06. No one: not HHS, not VaxGen and certainly not FDA actually explained what the problem was. The story was that the vaccine had a "stability" problem.

Take my word for it, that was not the problem. Bioport did not even have a stability testing program of any kind until 1997. FDA lets DOD give soldiers experimental vaccines that are stored in bulk for decades with no stability test, and no expiration date. FDA is not that excited about stability.

We know the first vaccine that VaxGen tried in humans was less effective than Bioport's, as expected. Bioport's vaccine had more antigenically active molecules, and animal studies had shown such vaccines worked better than the pure PA vaccines.

Was the VaxGen vaccine safer? The systemic reaction rate was higher than Bioport's in the Phase 1 safety trial. We have no info on serious side effects. Personally, I expect that both were unsafe.

The lack of purity is unlikely to be the reason for the high adverse reaction rate. Why? Because the versions of anthrax vaccine were just as impure between 1955 and 1989, but less concentrated, and there were fewer reactions then.

VaxGen then went on to take its original vaccine and add a secret, presumably experimental adjuvant. Such adjuvants made the vaccine highly effective in animal experiments, but safety of the adjuvants had never been established.

Gulf War vets who received either UK or US (and other) anthrax vaccines developed virtually similar illnesses. Later, since 1998, the two vaccines have led to similarly high reaction rates. Both have, coincidentally, also had similar manufacturing problems.

Both the US and UK anthrax vaccines are killed vaccines. What about developing a live, attenuated vaccine? Live vaccines do not require any adjuvants, experimental or otherwise. But live animal anthrax vaccines do kill occasional animals, usually goats and llamas. This occurs either because they have not been sufficiently attenuated during manufacturing, or because the animals are susceptible to residual virulence in the vaccine strain of anthrax. They work better than killed vaccines, but are less than 100% effective. The deaths of animals have been a big enough potential problem that live vaccines for humans were never developed in the US or UK. They are used occasionally in Russia and China, but very little is known of their safety or efficacy.

Maybe the problem is the vaccine's main protective ingredient, termed "Protective Antigen." It turns out that despite the name, ProtectiveAntigen, or PA, is not so harmless.

You might expect that the main ingredient of anthrax vaccine would have been carefully studied. You would be wrong. It is eye-opening to learn there are no animal toxicity studies in the prelicensing data packet given to the US licensing authority. The vaccine was given to pregnant soldiers before it was given to pregnant mice orguinea pigs. There are still no meaningful animal toxicology studies in the literature, despite at least one expert committee recommending them several years ago. Occasionally, experimental animals being used for efficacy studies developed health problems, and the author mentioned them, but that has been the extent of the animal safety literature.

There are no recent studies in which individual ingredients, such asPA, were given to animals to learn their adverse effects.There just may be a reason for this. Government anthrax researcherswho have been around for awhile, like Arthur Friedlander, probably know what they better not find.

Back in the late 1960s, two papers were published in which PA was injected into monkeys. Blood glucose levels went down, and other blood chemistry parameters shifted rapidly. In some monkeys, allelectrical brain activity stopped for several minutes. These are very toxic reactions! PA remains biologically active, and is exerting powerful effects.

These papers were published before the original anthrax vaccine was licensed. It seemed that once the vaccine got a license, and the possibility existed that many people might receive the vaccine, the government either ceased research on adverse effects, or did it"underground" -- and never published the results. The government owned (and still owns) the patent. It also owned the equipment used to manufacture the vaccine. It owns the stockpile of vaccine.

Virtually all recipients have been government employees, and virtually all medical professionals administering the vaccine and dealing with potential adverse effects have also been government employees. Conflict of interest? Anyway, I have come to suspect that you cannot make a vaccine thatcontains a lot of PA without it causing illnesses in susceptible recipients. The Brits could not, Bioport could not, and it surelooks like VaxGen couldn't either.

The "good" news is that several other immunogenic molecules have been recently discovered from anthrax. It might be possible to construct a vaccine out of these building blocks. But so far, no one has even suggested trying this approach.

Other "good" news is that many potentially excellent drugs to kill anthrax or stop its deadly effects are in development. So treatment following exposure is going to be a lot better if there ever is ananthrax attack. Government should take some of that $877 million it snatched out of VaxGen's hands, and get these products into animal trials, as well as manufacturing small amounts in advance, as was done with VaxGen's vaccine (for a wasted $200 plus million dollars).

"Government science" may be an oxymoron these days. But come on, government scientists, you may have to take this stuff too. Please put your thinking caps on and start doing the missing studies (hint-hint: animal toxicity, and obtaining meaningful toxicity and safety data from ongoing uses of anthrax vaccines, and from the CDC anthrax vaccine clinical trial). $100 million could give you a very good idea which of the new drugs are promising, and should be subjected to human safety and surrogate efficacy trials.

February 17, 2007

DoD Resumes Mandatory Anthrax Vaccinations - Army Times

Aviation electrician's mate 2nd class Brian Royal's first reaction when he heard the Defense Department will resume its mandatory anthrax vaccination program this month was to contact an attorney.

That decision came in spite of a December Food and Drug Administration ruling that the vaccine is safe and effective against all forms of anthrax.

His family, he said, has a strong history of following orders and paying for their loyalty later."My father was a Vietnam veteran," Royal e-mailed from Afghanistan. "He's suffering from personality disorders, and nervous and endocrine system damage that were likely a result of his exposure to Agent Orange. DoD claimed it was a safe and effective defoliant."

The history goes back further.

"My grandfather was present as an Army soldier for a Nevada nuclear test strike," he said. "He was marched into ground zero immediately following the strike. He's dying from multiple myeloma."

Multiple myeloma is an incurable plasma cancer that develops in the bone marrow.

"I feel like I'm following in their footsteps," Royal said. "That scares me."

Still, though a part of the John Doe et al v. Donald Rumsfeld class-action suit, which asks that the program be voluntary, Royal intends to continue the family history of following orders.

"I believe it to be an unacceptable risk," he said. "On the other hand, I'm not planning to defy a direct order by my superiors."

William Winkenwerder Jr., assistant secretary of defense for health affairs, approved the service implementation plans from each branch Feb. 8. After those plans are in place, each branch will begin the vaccinations, a Defense Department spokesman said.

The shots will be mandatory for everyone assigned to U.S. Central Command, including Iraq or Afghanistan, as well as forces in Korea.

The vaccinations have been controversial because, according to the FDA, 21 people have died after the vaccine, though none of those cases shows a direct cause-and-effect reaction to the vaccine. The FDA also tracked 4,279 reports of health problems from the vaccine from July 1990 to March 2005, with 390 listed as "serious."

But Defense Department officials say the vaccine is worthwhile because five people died from anthrax when 22 envelopes went out in the U.S. mail system in 2001.

Anthrax is usually found in cattle, which can then transfer the disease to humans. If the disease is passed by touch, it starts with a big, itchy boil with a black center where the skin is dying. A person infected with the disease by breathing it may feel as if he has a cold, but may quickly develop breathing problems and go into shock. And a person who ingests the bacteria will feel nauseated, lose his appetite, vomit, have a fever, vomit blood and suffer severe diarrhea.

Weaponized anthrax is inhaled.

The disease can be treated with antibiotics, but they are only effective if begun early, according to the Centers for Disease Control.

And the FDA just granted fast-track status to the BioThrax anthrax vaccine as a post-exposure treatment in conjunction with antibiotics. That means the development and review of the drug will be expedited, potentially killing the need to vaccinate troops. Defense Department officials had not responded as of Friday to questions about a new treatment that would cause them to rethink the mandatory vaccine policy.

A Defense Department spokesman said the services will keep their service members informed about the vaccine, as well as address any medical concerns. People can find out more about adverse reactions at http://www.anthrax.osd.mil

February 15, 2007

ALARACT - AVIP - Army Implementation of AVIP

http://www.vaccines.mil/documents/1007ALARACT_AVAcontinue.pdfPAAUZYUW RUEWMCS4918 0440114-UUUU__RUCRARM.ZNR UUUUU ZUI RUEWMCE8788 0440058P 130113Z FEB 07FM PTC WASHINGTON DC//ALARACT//TO ALARACTZEN/ALARACT @ AL ALARACT(UC)BTUNCLASSUBJ: ALARACT 024/2007ON BEHALF OF DA WASHINGTON DC//DASG//THIS ALARACT MESSAGE IS RELEASED ON BEHALF OF THE OFFICE OF THE SURGEONGENERAL.SUBJECT: ALARACT - ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)REF/A/DOC/ASD(FM&P)/10APR92/APMN/ASD(FM&P) DOD DIRECTIVE 1404.10,EMERGENCY-ESSENTIAL (E-E) DOD U.S. CITIZEN CIVILIAN EMPLOYEES//REF/B/DOC/ASD (FM&P)/26JAN96/APMN/ASD(FM&P) DOD INSTRUCTION 3020.37,CONTINUATION OF ESSENTIAL DOD CONTRACTOR SERVICES DURING CRISIS//REF/C/DOC/ASD (FMP)/25JUNE01/APMN/ASD(FMP) MEMO, SUBJ: NOTIFYINGEMERGENCY-ESSENTIAL EMPLOYEES REGARDING ANTHRAX IMMUNIZATIONREQUIREMENTS//REF/D/DOC/USD(P&R)/22SEP04/AMPN/USD(P&R) MEMO, SUBJ: EXPANSION OF FORCEHEALTH PROTECTION ANTHRAX AND SMALLPOX IMMUNIZATION PROGRAMS FOREMERGENCY-ESSENTIAL AND EQUIVALENT DOD CIVILIAN EMPLOYEES//REF/E/DOC/USD(P&R)/6AUG02/APMN/USD(P&R) MEMO, SUBJ: POLICY ONADMINISTRATIVE ISSUES RELATED TO ANTHRAX VACCINE IMMUNIZATION PROGRAM(AVIP)//REF/F/DOC/USD(P&R)/6AUG02/APMN/USD(P&R) MEMO, SUBJ: ADMINISTRATIVE ANDCLINICAL EXECUTION GUIDANCE FOR REINTRODUCTION OF THE ANTHRAX VACCINEIMMUNIZATION PROGRAM (AVIP)//REF/G/DOC/ASD(HA)/6AUG02/APMN/ASD(HA) MEMO, SUBJ: POLICY ON CLINICALISSUES RELATED TO ANTHRAX VACCINATION// REF/H/DOC/DASGHCA/24SEP02/APMN/DASG-HCA PLAN, SUBJ: ARMY ANTHRAX VACCINE IMMUNIZATIONPROGRAM RESUMPTION EXECUTION PLAN//REF/I/DOC/DEPSECDEF/28JUN04/APMN/DEPSECDEF MEMO, SUBJ: EXPANSION OFFORCE HEALTH PROTECTION ANTHRAX AND SMALLPOX IMMUNIZATION PROGRAMS FORDOD PERSONNEL//REF/J/MSG/HQDA/171854ZJUL04/APMN/ALARACT MSG, SUBJ: EXPANSION OFANTHRAX AND SMALLPOX VACCINATION PROGRAMS//REF/K/DOC/DEPSECDEF/12OCT06/APMN/DEPSECDEF MEMO, SUBJ: ANTHRAX VACCINEIMMUNIZATION PROGRAM (AVIP)//REF/L/DOC/USD(P&R)/6DEC06/APMN/USD(P&R) MEMO, SUBJ: ANTHRAX VACCINEIMMUNI ZATION PROGRAM (AVIP)//REF/M/DOC/CDC/24APR03/SUBJ: ANTHRAX VACCINE INFORMATION STATEMENT (VIS)HTTP://WWW.CDC.GOV/NIP/PUBLICATIONS/VIS/VIS-ANTHRAX.PDF//REF/N/DOC/ASD(HA)/3MAR03/APMN/ASD(HA) MEMO, SUBJ: REQUEST FOR EXCEPTIONTO POLICY FOR SMALLPOX AND ANTHRAX VACCINATIONS FOR SELECTED NORTHCOMFORCES//REF/O/DOC/CDC/1DEC06/SUBJ: GENERAL RECOMMENDATIONS ON IMMUNIZATIONS:RECOMMENDATIONS OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES(ACIP) MMWR 2006;55(NO. RR-15)//REF/P/DOC/DASG-HCA/24SEP02/APMN/DASG-HCA DOC, SUBJ: ARMY ANTHRAXVACCINE IMMUNIZATION PROGRAM PLAN//REF/Q/DOC/ASD(HA)/08FEB07/APMN/ASD(HA) MEMO, SUBJ: APPROVAL OF US ARMYANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) IMPLEMENTATION PLAN//1. (U) SITUATION.1.A. (U) GENERAL. ON 15 DEC 05, THE FOOD AND DRUG ADMINISTRATION(FDA) ISSUED A FINAL RULE AND FINAL ORDER ON THE LICENSURE OF ANTHRAXVACCINE ADSORBED (AVA) DETERMINING THAT AVA IS LICENSED FOR THEPREVENTION OF ANTHRAX, REGARDLESS OF ROUTE OF EXPOSURE. FOLLOWINGPUBLICATION OF THE FDA FINAL RULE AND FINAL ORDER, THE DEPARTMENT OFDEFENSE (DOD) UNDERTOOK A REVIEW OF BIODEFENSE VACCINATION PROGRAMS.ON 12 OCT 06, THE DEPUTY SECRETARY OF DEFENSE DIRECTED A RESUMPTION OFMANDATORY AVA IMMUNIZATIONS FOR PERSONNEL ASSIGNED TO DESIGNATEDGEOGRAPHIC LOCATIONS (HIGHER THREAT AREAS) OR TO SPECIAL MISSION UNITSAND VOLUNTARY AVA IMMUNIZATION IN ALL SERVICE MEMBERS ONLY PARTIALLYIMMUNIZED (REF K).1.A.1. (U) CONSISTENT WITH THE FDA APPROVED DOSING SCHEDULE FORANTHRAX VACCINE; ALL PERSONNEL WHO BEGIN THE SIX DOSE IMMUNIZATIONSERIES (UNLESS EXCLUDED FOR MEDICAL REASONS (REF G) OR ADMINISTRATIVEREASONS (REF F)) WILL BE OFFERED ALL SIX DOSES AND THE ANNUAL BOOSTERAS LONG AS THEY REMAIN MEMBERS OF THE ARMED FORCES ON ACTIVE DUTY OR INTHE SELECTED RESERVES OR MAINTAIN A CIVILIAN EMPLOYEE OR CONTRACTORSTATUS COVERED BY THE PROGRAM. FOR THOSE NO LONGER DEPLOYED TO AHIGHER THREAT AREA OR NO LONGER ASSIGNED TO DESIGNATED SPECIAL MISSIONROLES, COMPLETE-THE-SERIES AND ANNUAL BOOSTER DOSES WILL BE OFFERED ONA VOLUNTARY BASIS. IT IS DESIRABLE THAT ALL PERSONNEL DEPLOYING TOHIGHER-THREAT AREAS RECEIVE AT LEAST THEIR FIRST THREE DOSES PRIOR TODEPLOYMENT. IN THOSE RARE INSTANCES WHEN AN INDIVIDUAL IS NOT ABLE TOTAKE OR CONTINUE THE ANTHRAX SERIES DUE TO: (1) AN ADMINISTRATIVEEXEMPTION, GRANTED BY A COMMANDER OR SUPERVISOR; OR (2) A MEDICALEXEMPTION GRANTED BY A PRIVILEGED HEALTHCARE PROVIDER (E.G. PHYSICIANS,NURSE PRACTITIONERS, AND PHYSICIAN ASSISTANTS), THE INDIVIDUAL IS STILLDEPLOYABLE.1.A.2. (U) ON 6 DEC 06, THE UNDER SECRETARY OF DEFENSE FOR PERSONNELAND READINESS (USD(P&R)) ISSUED DETAILED INSTRUCTIONS (REF L) TOIMPLEMENT THE RESUMPTION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM(AVIP). ON 08 FEB 07 THE ASD(HA) APPROVED THE ARMY IMPLEMENTATIONPLAN.1.A.3. (U) THE DOD WILL RESUME AVA IMMUNIZATIONS CONSISTENT WITH THEFDA-LICENSED DOSE SCHEDULE (0, 2, AND 4-WEEKS, AND AT 6, 12 AND 18-MONTHS AND ANNUAL BOOSTERS) AND CURRENT STANDARDS FOR MEDICAL PRACTICE.SOLDIERS RECEIVING ONE OR MORE DOSES OF AVA, SINCE MARCH 1998, WHOSEPRIMARY IMMUNIZATION SERIES WAS INTERRUPTED WILL CONTINUE VACCINATIONWITH THE NEXT DOSE DUE. THEY WILL NOT RESTART THE SERIES. THIS ISCONSISTENT WITH THE RECOMMENDATIONS OF THE CENTERS FOR DISEASE CONTROLAND PREVENTION'S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)(REF O).1.A.4. (U) TO ENSURE ALL VACCINATION PROGRAM REQUIREMENTS AREFULFILLED, DISTRIBUTION OF ANTHRAX VACCINE WILL BE LIMITED TO SITESWHERE COMMAND-DESIGNATED LEADERS AFFIRM THEY HAVE READ THE PROGRAMREQUIREMENTS, COMPLETED TRAINING, AND WILL ENSURE THEY ARE FOLLOWED.THIS LEADER WILL COMPLETE A REGISTRY AGREEMENT AND A CHECKLIST, WHICHWILL THEN AUTHORIZE VACCINATIONS TO BEGIN. ORGANIZATIONS WITH APPROVEDREGISTRY AGREEMENTS MUST SUBMIT MONTHLY REPORTS TOAVIPREPORTS@AMEDD.ARMY.MIL OR VACCINES@HQDA-S.SMIL.MIL BY THE FIFTH OFEVERY MONTH. ORGANIZATIONS WITH PREVIOUSLY APPROVED COMPLIANCEAGREEMENTS ARE NOT REQUIRED TO SUBMIT A NEW REGISTRY AGREEMENT AS LONGAS THE ACCOUNTABLE LEADER HAS NOT CHANGED.2. (U) MISSION. AT THIS TIME, ARMY COMMANDS (ACOM), ARMY SERVICECOMMANDS (ASCC), AND DIRECT REPORTING UNITS (DRU) ARE DIRECTED TOIMPLEMENT THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) TO PROTECTPERSONNEL AT RISK FROM ANTHRAX SPORES.3. (U) EXECUTION. COMMANDERS INTENT. AC, ASCC, AND DRUS WILLIMPLEMENT THE RESUMPTION OF THE AVIP IMMEDIATELY WITH A GOAL OF 90% OFTHE MANDATORY POPULATION RESUMED OR STARTED THE VACCINE DOSING SCHEDULEBY 30 APR 07, IN ORDER TO PROTECT PERSONNEL FROM ANTHRAX BEFOREEXPOSURE. PRE-EXPOSURE VACCINATION OF OUR FORCES REMAINS THE MOSTEFFECTIVE ANTHRAX MEDICAL COUNTERMEASURE. THE ENDSTATE FOR THISIMPLEMENTATION PLAN IS ALL DOD PERSONNEL DETERMINED AT HIGHER RISK OFANTHRAX EXPOSURE, EXCLUDING THOSE MEDICALLY OR ADMINISTRATIVELYEXEMPTED, ARE PROTECTED AGAINST ANTHRAX THROUGH ACTIVE IMMUNIZATION.3.A. (U) CONCEPT OF OPERATION. THE ARMY ANTHRAX VACCINE IMMUNIZATIONPROGRAM PLAN (REF H) REMAINS IN FULL EFFECT. THE PROGRAM IS AMENDED TOINCLUDE FOLLOWING CHANGES:3.A.1. (U) THE FOLLOWING CATEGORIES OF INDIVIDUALS WILL RESUMEMANDATORY ANTHRAX VACCINATIONS, EXCEPT AS PROVIDED UNDER APPLICABLEMEDICAL AND ADMINISTRATIVE EXEMPTION POLICIES.3.A.1.a. (U) UNIFORMED PERSONNEL DEPLOYED OR DEPLOYING TO THE U.S.CENTRAL COMMAND (CENTCOM) AREA OF RESPONSIBILITY (AOR) FOR 15 OR MORECONSECUTIVE DAYS. THE CENTCOM HEADQUARTERS MAY PROVIDE ADDITIONALINSTRUCTIONS CONSISTENT WITH THIS MESSAGE FOR ALL COMPONENT MEDICALTREATMENT FACILITIES WITHIN THE CENTCOM AOR. VACCINATION CAN BEGIN ASEARLY AS 60 DAYS PRIOR TO DEPLOYMENT.3.A.1.b. (U) UNIFORMED PERSONNEL ASSIGNED TO OR DEPLOYING TO THEKOREAN PENINSULA FOR 15 OR MORE CONSECUTIVE DAYS. VACCINATION CANBEGIN AS EARLY AS 60 DAYS PRIOR TO DEPLOYMENT.3.A.1.c. (U) UNIFORMED PERSONNEL ASSIGNED TO SPECIAL UNITS WITHBIOWARFARE OR BIOTERRORISM-RELATED MISSIONS AND OTHER SPECIALLYDESIGNATED UNITS APPROVED AS EXCEPTION TO POLICY (REF N) UNDER THEPREVIOUS ANTHRAX VACCINATION POLICY. UNITS SUCH AS:3.A.1.c.1. (U) US ARMY AND US AIR NATIONAL GUARD WEAPONS OF MASSDESTRUCTION (WMD) CIVIL SUPPORT TEAMS.3.A.1.c.2. (U) 22ND AND 110TH CHEMICAL BATTALIONS, 20TH SUPPORTCOMMAND.3.A.1.c.3. (U) US ARMY AREA MEDICAL LABS (AML).3.A.1.c.4. (U) US ARMY RESERVE UNITS ASSIGNED TO NORTHCOM JOINT TASKFORCE - CIVIL SUPPORT (JTF-CS), CBRNE CONSEQUENCE MANAGEMENT RESPONSEFORCE (CCMRF)3.A.1.d. (U) DOD CIVILIAN EMPLOYEES.3.A.1.d.1. (U) AFTER ENSURING STATUTORY AND CONTRACTUAL LOCAL LABORRELATIONS OBLIGATIONS HAVE BEEN MET, UNIT LEADERS WILL BEGIN MANDATORYANTHRAX VACCINATION OF EMERGENCY-ESSENTIAL (E-E) AND EQUIVALENT DODCIVILIAN EMPLOYEES 18 TO 65 YEARS OLD SERVING IN CENTCOM AOR OR USFORCES KOREA FOR 15 OR MORE CONSECUTIVE DAYS OR OTHER DESIGNATED UNITS(REF A,C-G AND I). CONTACT LOCAL CIVILIAN PERSONNEL ADVISORY CENTERSFOR GUIDANCE ON MEETING LABOR-RELATIONS OBLIGATIONS. "EQUIVALENT"PERSONNEL MEANS OTHER PERSONNEL WHOSE DUTIES MEET ALL OF THEREQUIREMENTS OF 10 U.S.C. 1580, BUT WHO HAVE NOT BEEN DESIGNATED AS"EMERGENCY-ESSENTIAL." THE NOTIFICATION REQUIREMENTS OF 10 U.S.C.1580A AND DOD POLICY (REF C AND D) WILL BE FOLLOWED.3.A.1.d.2. (U) VACCINATION FOR THE EMERGENCY-ESSENTIAL AND EQUIVALENTCIVILIAN PERSONNEL IDENTIFIED ABOVE IS MANDATORY, SUBJECT TOESTABLISHED MEDICAL AND ADMINISTRATIVE EXEMPTION POLICIES. THESUPERVISOR AND COMMANDER IN CONJUNCTION WITH REPRESENTATIVES OF THECIVILIAN PERSONNEL OFFICE WILL DETERMINE THE EFFECT ON A DEPARTMENT OFTHE ARMY EMPLOYEE WHO REFUSES IMMUNIZATION WHEN INDICATED. INACCORDANCE WITH REFERENCE H, MANAGEMENT MUST FIRST CONSIDER TAKING ANON-ADVERSE ACTION, SUCH AS A (1) REASSIGNMENT TO A NON-E-E POSITION;(2) IDENTIFICATION OF AN ALTERNATE EMPLOYEE WHO IS WILLING TO BEIMMUNIZED AND SERVE AS AN E-E; OR (3) CURTAILMENT OF TOUR. IF NONE OFTHESE IS POSSIBLE, THE E-E COULD BE SUBJECT TO ADVERSE ACTIONS, UP TOAND INCLUDING, REMOVAL FROM THE FEDERAL SERVICE. REFUSAL OF ANTHRAXIMMUNIZATION SHOULD BE DOCUMENTED IN APPROPRIATE PERSONNEL AND HEALTHRECORDS.3.A.1.e. (U) DOD CONTRACTOR PERSONNEL CARRYING OUT MISSION-ESSENTIALSERVICES AND ASSIGNED FOR 15 OR MORE CONSECUTIVE DAYS TO THE U.S.CENTRAL COMMAND AREA OF RESPONSIBILITY OR KOREA (REF B,E-G AND I).CONTRACTS MUST SPECIFY IMMUNIZATION AS A REQUIREMENT. IMMUNIZATIONWILL BE PROVIDED THROUGH DOD MILITARY TREATMENT FACILITIES. FOR THISPURPOSE, EQUIVALENT PERSONNEL MEANS OTHER PERSONNEL WHOSE DUTIES MEETALL THE REQUIREMENTS OF 10 U.S.C. 1580, BUT WHO HAVE NOT BEENDESIGNATED AS "EMERGENCY-ESSENTIAL."3.A.2. (U) PERSONNEL ELIGIBLE FOR VOLUNTARY VACCINATIONS (SUBJECT TOMEDICAL EXEMPTIONS) BASED ON CURRENT LOCATION OR STATUS. THE FOLLOWINGINDIVIDUALS ARE ELIGIBLE FOR VOLUNTARY VACCINATIONS:3.A.2.a. (U) U.S. GOVERNMENT CIVILIAN EMPLOYEES AND U.S. CITIZENCONTRACTOR PERSONNEL 18-65 YEARS OLD OTHER THAN THOSE REFERRED TO INPARAGRAPHS 3.A.1.d. AND 3.A.1.e., ASSIGNED FOR 15 OR MORE CONSECUTIVEDAYS TO THE U.S. CENTRAL COMMAND AREA OF RESPONSIBILITY OR KOREA. FORCONTRACTORS, IMMUNIZATION REQUIREMENTS WILL BE SPECIFIED IN THECONTRACT AND ARE AVAILABLE THROUGH DOD MILITARY TREATMENT FACILITIES.3.A.2.b. (U) U.S. CITIZEN ADULT FAMILY MEMBERS, 18-65 YEARS OF AGE,ACCOMPANYING DOD MILITARY AND CIVILIAN PERSONNEL FOR 15 OR MORECONSECUTIVE DAYS TO THE U.S. CENTRAL COMMAND AREA OF RESPONSIBILITY ORTO THE KOREAN PENINSULA.3.A.2.c. (U) U.S. CITIZEN ADULT FAMILY MEMBERS, 18-65 YEARS OF AGE,ACCOMPANYING U.S. CONTRACTOR PERSONNEL FOR 15 OR MORE CONSECUTIVE DAYSTO THE U.S. CENTRAL COMMAND AREA OF RESPONSIBILITY OR TO THE KOREANPENINSULA, IF PROVIDED FOR IN THE CONTRACT.3.A.2.d. (U) VACCINE MANUFACTURING AND RESEARCH PERSONNEL ANDPERSONNEL DESIGNATED BY ASD(HA). ASD(HA) WILL APPROVE REQUESTS ON ACASE-BY-CASE BASIS.3.A.3. (U) THE FOLLOWING CATEGORIES OF INDIVIDUALS NOT SUBJECT TOMANDATORY VACCINATION, WHO RECEIVED AT LEAST ONE DOSE OF ANTHRAXVACCINE SINCE MARCH 1998 AND WHO WISH TO CONTINUE THE VACCINE DOSINGSERIES SHALL BE OFFERED ADDITIONAL VACCINE DOSES ON A VOLUNTARY BASIS.3.A.3.a. (U) UNIFORMED ACTIVE DUTY OR SELECTED RESERVE PERSONNEL,REGARDLESS OF CURRENT DUTY ASSIGNMENT, IF THEY PREVIOUSLY RECEIVED ATLEAST ONE DOSE OF ANTHRAX VACCINE SINCE MARCH 1998, AND IF THEY ARE NOTCURRENTLY SUBJECT TO MANDATORY VACCINATION. FOR THESE INDIVIDUALS,CONTINUING THE DOSING SERIES IS RECOMMENDED BUT NOT REQUIRED.3.A.3.b. (U) U.S. GOVERNMENT CIVILIAN EMPLOYEES, NO LONGER IN A HIGHERTHREAT AREA, WHO HAVE RECEIVED AT LEAST ONE DOSE OF ANTHRAX VACCINE.3.A.3.c. (U) OTHER INDIVIDUALS APPROVED BY ASD(HA) CONSISTENT WITHREFERENCE L. COMMANDERS WILL SUBMIT REQUESTS FOR EXCEPTIONS TO POLICYTHROUGH COMMAND CHANNELS TO HQDA, OFFICE OF THE SURGEON GENERAL,MILITARY VACCINE AGENCY, 5113 LEESBURG PIKE, FALLS CHURCH, VA 22041 FORAPPROVAL AND FOR COORDINATION WITH GAINING COMBATANT COMMAND, CJCS ANDASD(HA).3.B. (U) COORDINATING INSTRUCTIONS.3.B.1. (U) LEGAL.3.B.1.a. (U) COMMANDERS WILL ENSURE THAT SOLDIERS ARE CONTINUALLYEDUCATED CONCERNING THE INTENT AND RATIONALE FOR BOTH ROUTINE ANDTHEATER-SPECIFIC OR THREAT-SPECIFIC MILITARY IMMUNIZATION STANDARDS.IMMUNIZATIONS REQUIRED BY AR 40-562 OR OTHER LEGAL DIRECTIVE MAY BEGIVEN INVOLUNTARILY (EXCEPT AS PRESCRIBED IN AR 600-20, PARA 5-6). THEINTENT OF THIS AUTHORIZATION IS TO PROTECT THE HEALTH AND OVERALLEFFECTIVENESS OF THE COMMAND, AS WELL AS THE HEALTH OF THE INDIVIDUALSOLDIER. IN CASES WHERE A SOLDIER REFUSES A MANDATORY VACCINATION, THEFOLLOWING PROCEDURES AND LIMITATIONS APPLY.3.B.1.b. (U)UNDER NORMAL CIRCUMSTANCES, ACTIONS WILL NOT BE TAKEN TOINVOLUNTARILY IMMUNIZE SOLDIERS. IF A SOLDIER DECLINES TO BE IMMUNIZEDTHE COMMANDER WILL:3.B.1.b.1. (U) ENSURE THAT THE SOLDIER UNDERSTANDS THE PURPOSE OF THEVACCINE.3.B.1.b.2. (U) ENSURE THAT THE SOLDIER HAS BEEN ADVISED OF THEPOSSIBILITY THAT THE DISEASE MAY BE NATURALLY PRESENT IN A POSSIBLEAREA OF OPERATION OR MAY BE USED AS A BIOLOGICAL WEAPON AGAINST THEUNITED STATES AND ITS ALLIES.3.B.1.b.3. (U) ENSURE THAT THE SERVICE MEMBER IS EDUCATED ABOUT THEVACCINE AND HAS BEEN ABLE TO DISCUSS ANY OBJECTIONS WITH MEDICALAUTHORITIES.3.B.1.b.4. (U) COUNSEL THE SOLDIER, IN WRITING, THAT HE OR SHE ISLEGALLY REQUIRED TO BE IMMUNIZED AND THAT FAILURE TO OBEY THE ORDER MAYRESULT IN UNIFORM CODE OF MILITARY JUSTICE (UCMJ) AND/OR ADMINISTRATIVEACTION FOR FAILURE TO OBEY A LAWFUL ORDER (UCMJ, ARTICLE 92) AS DEEMEDAPPROPRIATE BY THE COMMANDER.3.B.1.c. (U) IF, AFTER ANY OF THE STEPS LISTED IN PARAGRAPH 3.B.1.b.,A SOLDIER ELECTS TO BE IMMUNIZED, ADVERSE ACTION WILL NOT NORMALLY BETAKEN BASED SOLELY ON THE INITIAL DECLINATION.3.B.2. (U) SCREENING. ALL IMMUNIZATION CLINICS AND SRP SITES SHOULDSCREEN ALL PERSONNEL RECEIVING ANTHRAX VACCINATIONS TO IDENTIFY IFVACCINATION IS REQUIRED OR VOLUNTARY AND TO ENSURE THERE ARE NOCONTRAINDICATIONS FOR RECEIVING THE VACCINE. CLINIC LEADERSHIP WILLESTABLISH AND IMPLEMENT QUALITY CONTROL MEASURES TO PREVENT ERRORS(E.G. MANDATORY VACCINATIONS OF INDIVIDUALS IN THE VOLUNTARY CATEGORY)INCONSISTENT WITH THIS POLICY. FOLLOW CURRENT CDC AND SERVICEGUIDELINES.3.B.3. (U) SOLDIERS RESUMING ANTHRAX VACCINATIONS WILL CONTINUE THEDOSING SERIES WITH THE NEXT DOSE DUE. THESE SOLDIERS WILL NOT NEED TOREPEAT ANY DOSES ALREADY RECEIVED OR RESTART THE SERIES. THIS ISCONSISTENT WITH GUIDANCE FROM THE CENTERS FOR DISEASE CONTROL ANDPREVENTION (CDC), THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES(ACIP) AND THE FOOD AND DRUG ADMINISTRATION (FDA).3.B.4. (U) UPON REDEPLOYMENT TO CONUS FROM THE USCENTCOM AOR OR THEKOREAN PENINSULA, PERSONNEL WILL NO LONGER BE REQUIRED TO RECEIVEMANDATORY ANTHRAX IMMUNIZATIONS.3.B.5. AVIP REGISTRY AGREEMENTS.3.B.5.a. (U) UNITS WITH CURRENT AGREEMENTS TO PARTICIPATE IN THEANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) CAN CONTINUE TO ORDERANTHRAX VACCINE AND IMMUNIZE SOLDIERS IAW THIS POLICY.3.B.5.b. (U) UNITS WISHING TO PROVIDE ANTHRAX VACCINATIONS IAW THISPOLICY MUST ACCOMPLISH THE FOLLOWING:3.B.5.b.1. (U) DESIGNATE A RESPONSIBLE LEADER AND HAVE THEM READ THEPROGRAM REQUIREMENTS AVAILABLE AT WWW.ANTHRAX.MIL/AVIP2007.3.B.5.b.2. (U) COMPLETE REQUIRED TRAINING.3.B.5.b.3. (U) COMPLETE THE REGISTRY AGREEMENT FORM AND CHECKLIST,AVAILABLE AT WWW.ANTHRAX.MIL/AVIP2007, AND SUBMIT TO THE MILITARYVACCINE AGENCY (MILVAX), AT AVIPREPORTS@AMEDD.ARMY.MIL, FOR APPROVAL.3.B.5.c. (U) ORGANIZATIONS CAN ORDER ANTHRAX VACCINE AND IMMUNIZESOLDIERS UPON RECEIPT OF APPROVED REGISTRY AGREEMENT.3.B.5.d. (U) THE AVIP REGISTRY AGREEMENT REQUIRES UNITS TO SUBMIT AMONTHLY REPORT BY THE FIFTH OF EACH MONTH FOR ACTIVITIES OF THEPREVIOUS MONTH. IN THE REPORT, DESCRIBE ANY UNAUTHORIZED IMMUNIZATIONSIDENTIFIED DURING THE INTERVAL OF THE REPORT, EVEN IF THE EVENTOCCURRED BEFORE THAT INTERVAL (BACK TO 27 OCT 04). REPORT ANYUNAUTHORIZED IMMUNIZATIONS TO THE MILVAX AGENCY AS SOON AS RECOGNIZED,WITHOUT WAITING FOR THE NEXT REPORT CYCLE.3.B.6. (U) COMMANDS ISSUING ORDERS FOR PERMANENT CHANGE OF STATION,TEMPORARY DUTY OR ANNUAL TRAINING LASTING MORE THAN 15 CONSECUTIVE DAYSTO LOCATIONS COVERED BY THE MANDATORY PROGRAM, WILL INCLUDE IN THEORDERS THE REQUIREMENT TO START OR RESUME ANTHRAX VACCINATIONS AT THELOSING INSTALLATION NOT EARLIER THAN 60 DAYS PRIOR TO ARRIVAL IN KOREAOR US CENTCOM AOR TO THE MAXIMUM EXTENT POSSIBLE. THE GOAL IS TOACHIEVE AT LEAST THE FIRST THREE DOSES OF THE SIX-DOSE SERIES ANDANNUAL BOOSTER PRIOR TO ARRIVAL IN THEATER.3.B.7. (U) ALL REFERENCES, A-P, REMAIN IN EFFECT.3.B.8. (U) ISSUES UNIQUE TO THE RESERVE COMPONENTS (RC).3.B.8.a. (U) MOST SOLDIERS BEING MOBILIZED FOR DEPLOYMENT TO A HIGHERTHREAT AREA REQUIRING ANTHRAX VACCINATIONS WILL RECEIVE MANDATORYANTHRAX VACCINATIONS AFTER ARRIVING AT THE MOBILIZATION STATION. INCASES WHERE RC SOLDIERS WILL BE IN A HIGHER THREAT AREA FOR 15 DAYS ORMORE (EXCLUDING TRAVEL TIME) ON ANNUAL TRAINING OR OTHER DUTY ORDERS,UNITS WILL COORDINATE FOR TIMELY VACCINATION OF THESE SOLDIERS THROUGHTHEIR CHAIN OF COMMAND TO THE ARMY RESERVE SURGEONS OFFICE (FOR USARSOLDIERS AND UNITS) OR THEIR STATE SURGEON'S OFFICE (FOR ARNG UNITS).3.B.8.b. (U) PERSONNEL SHALL BE IN A DUTY STATUS WHEN RECEIVING ANYDOD-DIRECTED IMMUNIZATION. UNIT COMMANDERS MUST ENSURE PERSONNELRECEIVING ANTHRAX VACCINATION ARE ELIGIBLE AND ARE IN A DUTY STATUS.DUAL-STATUS MILITARY TECHNICIANS MUST BE IN A MILITARY STATUS TORECEIVE VACCINATIONS.3.B.8.c. (U) RESERVE COMPONENT MEMBERS WHO INCUR OR AGGRAVATE ANYINJURY, ILLNESS, OR DISEASE WHILE PERFORMING ACTIVE DUTY FOR LESS THAN30 DAYS, OR ON INACTIVE DUTY TRAINING STATUS ARE ENTITLED TO MEDICALCARE APPROPRIATE FOR THE TREATMENT OF THE INJURY, ILLNESS OR DISEASE.AN ADVERSE REACTION FROM A DOD-DIRECTED IMMUNIZATION IS A LINE OF DUTYCONDITION. THEREFORE, WHEN A MEMBER OF THE RC PRESENTS FOR TREATMENT ATA MILITARY TREATMENT FACILITY (MTF), EXPRESSING A BELIEF THAT THECONDITION FOR WHICH TREATMENT IS SOUGHT IS RELATED TO RECEIVING ANIMMUNIZATION DURING A PERIOD OF DUTY, THE MEMBER MUST BE EXAMINED ANDPROVIDED NECESSARY MEDICAL CARE.3.B.8.d. (U) WHEN TREATMENT HAS BEEN RENDERED OR THE INDIVIDUAL'SEMERGENT CONDITION IS STABILIZED, A LINE OF DUTY AND/OR NOTICE OFELIGIBILITY WILL BE DETERMINED AS SOON AS POSSIBLE. FOR INJURIES,ILLNESS OR DISEASE UNRELATED TO DUTY, RC MEMBERS SHOULD SEEK MEDICALATTENTION FROM THEIR PERSONAL HEALTHCARE PROVIDERS.4. (U) ADMINISTRATION AND LOGISTICS.4.A. (U) THE ANTHRAX VACCINATION PROGRAM REMAINS A COMMANDERS FORCEHEALTH PROTECTION RESPONSIBILITY. COMMANDERS WILL FOLLOW GUIDANCEPROVIDED TO PROPERLY IDENTIFY AND EDUCATE SERVICE MEMBERS AND DODCIVILIANS TO BE VACCINATED, TRACK IMMUNIZATIONS, AND ENSURE APPROPRIATEMEDICAL EVALUATION IF THEY EXPERIENCE SYMPTOMS FOLLOWING ANYVACCINATION.4.A.1. (U) EDUCATION. EXPERIENCE SHOWS THAT EDUCATION IS PIVOTAL TOAVIP SUCCESS AND SOLDIER ACCEPTABILITY. LEADERS SHOULD REVIEW THE"EDUCATION TOOL KIT" AND THE "QUESTION AND ANSWERS" POSTED ON THEWEBSITE, WWW.ANTHRAX.MIL/AVIP2007 OR WWW.VACCINES.MIL/ANTHRAX GIVENTHAT THESE ARE THE MOST FREQUENTLY ASKED BY TROOPS AND THEIR FAMILIES.UNCLASSIFIED REFERENCES AND PROCEDURES AND EDUCATIONAL TOOLS AREAVAILABLE AT THE SAME LOCATION.4.A.2. (U) KEY MESSAGES.4.A.2.a. (U) YOUR HEALTH AND SAFETY ARE OUR NUMBER 1 CONCERNS 4.A.2.b.(U) THE VACCINE IS SAFE AND EFFECTIVE.4.A.2.c. (U) THE THREAT FROM ANTHRAX IS DEADLY AND REAL.4.A.2.d. (U) VACCINATION OFFERS A LAYER OF PROTECTION IN ADDITION TOANTIBIOTICS AND OTHER MEASURES THAT IS NEEDED FOR CERTAIN MEMBERS OFTHE ARMED FORCES.4.A.3. (U) VACCINE INFORMATION STATEMENTS (VIS) ARE AVAILABLE ATWWW.ANTHRAX.MIL (REF M).4.A.4. (U) MEDICAL ISSUES.4.A.4.a. (U) PREGNANCY. PREGNANT WOMEN SHOULD BE VACCINATED AGAINSTANTHRAX ONLY IF THE POTENTIAL BENEFITS OF VACCINATION OUTWEIGH THEPOTENTIAL RISKS TO THE FETUS. IMMUNIZATION CLINICS AND PROVIDERS WILLDISPLAY A PROMINENT WRITTEN SIGN DIRECTING WOMEN TO ALERT THETECHNICIAN OR PROVIDER IF THEY THINK THEY MIGHT BE PREGNANT.4.A.4.b. (U) ALL FEMALES OF CHILDBEARING AGE WILL BE ASKED ABOUT THEPOSSIBILITY OF PREGNANCY PRIOR TO RECEIVING THE VACCINE. THE FOLLOWINGQUESTION, RECOMMENDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION(CDC), SHOULD BE USED ON ANY LOCALLY APPROVED QUESTIONNAIRE /OVERPRINT, "ARE YOU PREGNANT OR IS THERE A CHANCE YOU COULD BECOMEPREGNANT DURING THE NEXT MONTH?". IF WOMEN HAVE ANY QUESTIONS ORCONCERNS, THEY SHOULD CONSULT WITH THEIR HEALTHCARE PROVIDER BEFORERECEIVING THE VACCINE.4.B. (U) COLLECT ALL PREVIOUS AVIP TRIFOLD BROCHURES FROM DECEMBER2005 OR EARLIER AND DISCARD THEM. DO NOT RETAIN THEM FOR FUTURE USE.BE SURE TO REMOVE OBSOLETE TRIFOLDS FROM PAMPHLET RACKS IN WAITINGROOMS, ON BULLETIN BOARDS, INTRANETS, ETC.4.C. (U) LOGISTICS.4.C.1. (U) END-USERS WILL DIRECTLY REQUISITION VACCINE IAW USAMMAGUIDELINES IN THE ARMY ANTHRAX IMPLEMENTATION PLAN (REF P).4.C.2. (U) LOCAL MEDICAL LOGISTICS SUPPORTING ELEMENTS MUST HAVESUFFICIENT REFRIGERATION CAPACITY TO PRESERVE VACCINE INTEGRITY,INCLUDING TEMPERATURE ALARMS AND BACK-UP POWER CAPACITY.4.C.3. (U) DISTRIBUTION OF VACCINE AND EDUCATIONAL TRIFOLDS FROMUSAMMA:4.C.3.a. (U) THE US ARMY MEDICAL MATERIEL AGENCY(USAMMA)IS RESPONSIBLEFOR COORDINATING THE DISTRIBUTION OF ANTHRAX VACCINE WITHIN DOD.4.C.3.b. (U) USAMMA DISTRIBUTION OPERATIONS CENTER, COM:301-619-4318/7235/4198, DSN: 343-4318/7235/4198, FAX: DSN 343-4468.4.C.3.c. (U) WEBSITE: WWW.USAMMA.ARMY.MIL AND THEN CLICK ONVACCINES/TEMPERATURE SENSITIVE PRODUCTS. INSTRUCTION ON ORDERING CANBE FOUND AT HTTP://WWW.USAMMA.ARMY.MIL/VACCINES/ANTHRAX/ANTXHOME.HTM.4.C.3.d. (U) WHEN USAMMA RECEIVES THE VACCINE ORDER, THEY WILL SHIPAVIP TRIFOLDS (DATED 12 OCTOBER 2006 OR LATER) TO THE REQUESTOR (ONEFOR EACH DOSE ORDERED). TRIFOLDS SENT WITH THE VACCINE ARE FORIMMUNIZATION CLINIC TO DISSEMINATE TO PATIENTS.4.C.3.e. (U) INSTALLATIONS CAN ALSO ORDER TRIFOLDS FOR USE IN THEEDUCATION PROGRAM FOR COMMANDERS, AVIP TEAM MEMBERS, AND OTHER KEYPERSONNEL. ADDITIONAL TRIFOLDS FOR POST-WIDE EDUCATION OR COMMANDER'SCALLS CAN BE ORDERED DIRECTLY FROM USAMMA OR DOWNLOADED FROM THE MILVAXWEBSITE.4.C.3.f. (U) ORDERING TRIFOLDS FOR PROGRAM START-UP EDUCATIONALPURPOSES: E-MAIL USAMMADOC@DET.AMEDD.ARMY.MIL ORVACCINES@AMEDD.ARMY.MIL, PLACING "TRIFOLD ORDER" IN THE SUBJECT LINE.STATE NUMBER OF TRIFOLDS NEEDED FOR EDUCATION PURPOSES AND PROVIDESHIPPING ADDRESS.4.C.3.g. (U) ANTHRAX VACCINE IS HEAT AND COLD SENSITIVE. THE VACCINEMUST BE STORED WITHIN THE APPROPRIATE TEMPERATURE RANGE (2-8 DEGREESCELSIUS)THROUGHOUT THE ENTIRE VACCINATION PROCESS. IT SHOULD BEREMOVED JUST PRIOR TO ADMINISTERING THE SHOT. THIS VACCINE GENERALLYSHOULD NOT BE "PRE-DRAWN" FOR ADMINISTRATION. THE USAMMA WEBSITEPROVIDES ADDITIONAL GUIDANCE ON HANDLING, STORAGE, TRANSPORTATION, ANDADMINISTRATION OF ANTHRAX VACCINE. WEBSITE: WWW.USAMMA.ARMY.MIL ANDTHEN CLICK ON VACCINES/TEMPERATURE SENSITIVE PRODUCTS.4.C.3.h. (U) EMAIL: USAMMADOC@DET.AMEDD.ARMY.MIL.4.D. (U) DOSING SCHEDULE.4.D.1. (U) PEOPLE RESUMING ANTHRAX VACCINATIONS UNDER THIS POLICY WILLCONTINUE THE DOSING SERIES WITH THE NEXT DOSE DUE. THEY WILL NOT NEEDTO REPEAT ANY DOSES ALREADY RECEIVED OR RESTART THE SERIES. THIS ISCONSISTENT WITH GUIDANCE FROM THE CDC AND ITS ADVISORY COMMITTEE ONIMMUNIZATION PRACTICES (ACIP). WHEN A DOSE CANNOT BE PROVIDED ON THESPECIFIC DATE SUGGESTED BY THE SCHEDULE, PROVIDE IT AS SOON ASPRACTICAL THEREAFTER. DO NOT SHORTEN THE RECOMMENDED INTERVALS BETWEENDOSES.4.D.2. (U) ALL COMMANDS AND MEDICAL TREATMENT FACILITIES SHOULDDEVELOP ROUTINE PROCEDURES TO DETERMINE WHEN PERSONNEL NEED SUBSEQUENTDOSES OF ANTHRAX VACCINE, UNLESS MEDICALLY OR ADMINISTRATIVELY EXEMPT,AT EACH OF THE FOLLOWING OPPORTUNITIES:4.D.2.a. (U) DURING IN- AND OUT-PROCESSING TO AN INSTALLATION, UNIT,OR TRAINING SCHOOLS.4.D.2.b. (U) WHEN SCREENING FOR INFLUENZA OR OTHER IMMUNIZATIONS.4.D.2.c. (U) BASED ON ELECTRONIC IMMUNIZATION TRACKING SYSTEM SHOTSDUEREPORTS.4.D.2.d. (U) DURING DEPLOYMENT READINESS PROCESSING IN PREPARATION FOROVERSEAS MOVEMENT.4.D.2.e. (U) UPON REDEPLOYMENT FROM A COMBAT ZONE.4.D.2.f. (U) DURING BIRTH-MONTH PERSONNEL AND MEDICAL RECORDS AUDITS.4.D.2.g. (U) DURING PERIODIC HEALTH ASSESSMENTS.4.D.2.h. (U) DURING OTHER ROUTINE OR OTHER PERIODIC ENCOUNTERS.4.E. (U) VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS).4.E.1. (U) SUBMISSION OF VAERS REPORTS SHOULD BE ENCOURAGED BYPROVIDERS WHO BELIEVE IT IS WARRANTED AND BY ANY PATIENT WHO BELIEVESTHAT THEY HAVE HAD AN UNUSUAL OR SEVERE REACTION.4.E.2. (U) AR 40-562, IMMUNIZATIONS AND CHEMOPROPHYLAXIS, 29 SEP 06,ESTABLISHES MINIMUM REQUIREMENTS FOR SUBMISSION OF A VAERS-1: VACCINEREACTIONS RESULTING IN HOSPITALIZATION OR TIME LOST FROM DUTY (MORETHAN 24 HOURS), OR IF CONTAMINATED LOTS ARE SUSPECTED.4.E.3. (U) THE VAERS REPORTS CAN BE SUBMITTED DIRECTLY TO THEWWW.VAERS.HHS.GOV SITE. SUBMISSION OF A VAERS-1 REPORT IS NOT ANINDICTMENT AGAINST A VACCINE, IT SIMPLY FACILITATES REVIEW OFTEMPORALLY ASSOCIATED SYMPTOMS AND ADDS TO THE SAFETY DATABASE FOR EACHVACCINE.4.F. (U) VACCINE HEALTHCARE SYSTEMS (VHC) NETWORK.4.F.1. (U) CONTINUE TO EDUCATE LEADERS, HEALTHCARE PROVIDERS, ANDPATIENTS ABOUT THE SERVICES OFFERED BY THE VHC NETWORK.4.F.2. (U) THE VHC NETWORK IS A TEAM OF CLINICAL VACCINE EXPERTS WHOASSIST PATIENTS AND HEALTHCARE PROVIDERS WITH TREATMENT OF HEALTHPROBLEMS BEFORE AND AFTER VACCINATIONS, ASSIST WITH MEDICAL EXEMPTIONS,AND TEACH SERVICE MEMBERS AND THEIR FAMILIES ABOUT VACCINES. THE VHCCAN ALSO ASSIST WITH FILING VAERS REPORTS AND DOCUMENT EXEMPTIONS.4.F.3. (U) ARMY REGIONAL VHCS ARE LOCATED AT WALTER REED ARMY MEDICALCENTER, WASHINGTON, DC (COM: 202-782-0411; DSN 662-0411) AND FORTBRAGG, NC (COM: 910-432-4015; DSN 239-4015).4.F.4. (U) ANYONE WITH VACCINE RELATED QUESTIONS CAN ALSO CONTACT THEDOD CLINICAL CALL CENTER'S 24-HOUR TOLL-FREE NUMBER AT 1-866-210-6469.5. (U) COMMAND AND CONTROL.5.A. (U) COMMAND RELATIONSHIPS. COMMAND AND CONTROL RELATIONSHIPSREMAIN UNCHANGED UNDER THIS IMPLEMENTATION PLAN.5.B. (U) COMMAND, CONTROL, COMMUNICATIONS AND COMPUTER SYSTEMS (C4).5.B.1. (U) DOCUMENTATION. ALL INDIVIDUAL IMMUNIZATIONS, INCLUDINGCIVILIAN EMPLOYEES AND CONTRACT PERSONNEL, WILL BE IMMEDIATELY POSTEDAND TRACKED IN THE MEDICAL PROTECTION SYSTEM (MEDPROS), THE HQDASTANDARD FOR TRACKING ALL INDIVIDUAL MEDICAL READINESS INDICATORS INTHE ACTIVE AND RESERVE COMPONENTS. LEADERS AT ALL LEVELS CAN TRACKINDIVIDUAL AND UNIT COMPLIANCE USING MEDPROS, A MODERN, EASY TO USE,WEB-BASED TRACKING SYSTEM, ACCESSED ON THE INTERNET ATWWW.MODS.ARMY.MIL. USERS MAY OBTAIN INFORMATION ON HOW TO OBTAIN ALOGON ID DIRECTLY FROM THE WEBSITE OR BY CALLING THE MODS HELP DESK,DSN: 761-4976 OR E-MAIL MODS-HELP@ASMR.COM FOR ASSISTANCE. COMMANDERSWILL ASSIGN DESIGNATED PERSONNEL TO ROUTINELY ACCESS MEDPROS TO KEEPTHEIR UNITS STATUS CURRENT.5.B.2. (U) SOLDIERS MAY MONITOR AVA DOSES RECORDED IN MEDPROS BYACCESSING THEIR ON-LINE SHOT RECORD IN ARMY KNOWLEDGE ONLINE (AKO). TOVIEW OR PRINT INDIVIDUAL SHOT RECORDS, GO TO THE "MY MEDICAL" PAGE ANDSELECT MY MEDICAL READINESS AND THEN SELECT "VIEW DETAILED INFORMATION"UNDER THE IMMUNIZATION PROFILE STOPLIGHT. THE SELECTED LINK PROVIDES ALINK TO VIEW DOCUMENTED IMMUNIZATIONS.5.B.3. (U) CIVILIAN EMPLOYEES AND CONTRACT PERSONNEL SHOULD BE GIVEN ACOPY OF THEIR MEDPROS IMMUNIZATION RECORD (DD FORM 2766C) BY THE MTFWHERE THEY ARE IMMUNIZED AND/OR WHERE THEIR IMMUNIZATION INFORMATION ISENTERED INTO MEDPROS.5.C. (U) HQDA POCS FOR THIS MESSAGE ARE COL RANDALL ANDERSON OR LTCDAVID BEAUCHENE, COM: 703-681-5101 OR DSN: 761-5101, OR EMAIL:VACCINES@AMEDD.ARMY.MIL OR VACCINES@HQDA-S.ARMY.SMIL.MIL (ATTENTION:MILVAX).6. (U) EXPIRATION DATE CANNOT BE DETERMINED.BT

Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax(R) (Anthrax Vaccine Adsorbed) as a post-exposure prophylaxis against anthrax infection. BioThrax is the only FDA approved product for pre-exposure prophylaxis of anthrax infection. The company plans to seek FDA approval of BioThrax for use in combination with antibiotics as a post-exposure prophylaxis for anthrax infection.

The company is targeting a three dose regimen given two weeks apart for this indication. "We are extremely pleased that the FDA has taken this step as we continue our efforts to expand the label indication for BioThrax to include, in combination with antibiotics, its use for post-exposure prophylaxis for anthrax infection," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

"Our ongoing BioThrax enhancement programs are critically important and are designed to address the U.S. government's requirements in protecting our front-line forces as well as to building a national stockpile of safe and effective countermeasures against the use of anthrax as a weapon of bioterrorism. "

Under the FDA Modernization Act of 1997, Fast Track designation expedites the development and review of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

BioThrax Post-Exposure Development Program Currently, the company has an ongoing development program to expand the licensed label indications for BioThrax to include post-exposure prophylaxis when used in conjunction with antibiotics. In support of this expanded label indication, the company is conducting clinical trials, as well as non-clinical trials in accordance with the FDA's animal rule.

If the results from these studies are favorable, the company would anticipate filing with the FDA a biologics license application (BLA) supplement for marketing approval of BioThrax for this indication. The scientific information discussed in this press release related to the use of BioThrax in combination with antibiotic therapy as a post-exposure prophylaxis for anthrax infection is preliminary and investigative.

BioThrax is not currently approved by the FDA for this purpose, and no conclusions can or should be drawn regarding the safety or effectiveness of BioThrax for this purpose. Only the FDA can determine whether BioThrax is safe and effective for this purpose. Healthcare professionals should refer to and rely upon the FDA-approved labeling for BioThrax, and not the information discussed in this press release.

AIDS - Hit South Africa to Hold Mass-Scale HIV Vaccine Trial

The first mass trial of an HIV vaccine which has yielded promising results in smaller tests in the United States and elsewhere is to be launched in AIDS-hit South Africa, it was announced.

The South African AIDS Vaccine Initiative said the programme, baptised Phambili or "Going Forward" in the Xhosa language, will be conducted jointly with the HIV Vaccine Trials Network of the US National Institutes of Health.

"Three thousand participants will be recruited from four South African provinces -- Gauteng, North West, Western Cape and KwaZulu-Natal," it said in a statement.

The trial sites include the township of Soweto outside Johannesburg, Cape Town and Durban.

The "test of concept" vaccine, developed by US firm Merck, has been tried on more than 1,800 people across the United States, Canada, Latin America, the Caribbean and Australia.

The vaccine contains three HIV genes but not live HIV and therefore cannot infect volunteers.Lawrence Corey, lead researcher for the HVTN conducting the study said: "This trial will answer several major scientific issues that face all of us in the field of HIV-vaccine development.

"It will determine the usefulness of vaccines that induce high immune response to the parts of the virus that are similar between different strains of HIV."

South Africa has one of the world's highest rates of HIV infections, with more than 5.5 million infected people out of the national population of 47 million.

In the more-than 25-year history of AIDS, only one prototype vaccine, AIDSVAX, has completed the vast process of human trials and it proved to be a disappointing failure.

Making the HPV Vaccine Mandatory is Bad Medicine (mentions AVA)

Governor Rick Perry’s decision to sidestep the Texas legislature and issue an executive order mandating that girls entering the 6th grade receive the new HPV vaccine raises troubling questions about the influence pharmaceutical companies wield on the crafting of public health policy. Cervical cancer is only expected to cause 3670 deaths in the US in 2007, a miniscule percentage (less than 2%) of the 270,000 deaths from the disease worldwide and only 1% of the total annual number of deaths from all cancers in the United States.

While cervical cancer used to be one of the deadliest diseases for women in the US, the number of deaths it causes has dropped dramatically (by 74% from 1955-1992) and it continues to drop). Why then are so many states considering mandating a vaccine that costs $300-$500 per patient for a type of cancer that is already largely under control in this country and which can be almost entirely prevented by regular gynecological checkups and Pap smears?

Merck & Co., the giant pharmaceutical company that makes the vaccine Gardasil, is spending millions of dollars lobbying state legislators. In Texas, where Merck recently doubled its lobbying efforts, Gov. Perry received $6000 from Merck’s political action committee during his last campaign. One of Merck’s key lobbyists in Texas is Perry’s former chief-of-staff and the mother-in-law of his current chief-of-staff is the state director of Women in Government, a national advocacy group of female state legislators that has received substantial funds from Merck.

It is important to note that low income women and women who do not have health insurance are most at risk because they are less likely to get regular Pap smears. More than half of the diagnosed cases of cervical cancer are in women who have not had a Pap smear in three years. While Gov. Perry has mandated that the state of Texas foot the bill for those who can’t afford the expensive HPV vaccine, it is unclear where those funds would come from either in Texas or in other states that are considering making the vaccine mandatory. And obviously the cost of the vaccine makes it prohibitive in the countries where it is most needed and would potentially do the most good.

What is clear is that Merck has a substantial financial interest in the vaccine becoming mandatory even though the added benefit to public health is both minimal and costly. With more than 10 million girls in the US between the ages of 10-14, the drug company stands to make billions of dollars preventing a disease that is already treatable in the targeted population. Since the vaccine does not eliminate the need for regular Pap smears, it would appear that a far more appropriate and cost effective first step would be to make regular gynecological healthcare available for all women regardless of income and medical insurance, particularly since this step by itself would go a long way in reducing the few cases of cervical cancer that still occur in this country.

There is however another significant public health concern in regards to the HPV vaccine, namely that it is a very new drug with no history. We are of course being told that it is perfectly safe and has few side effects, but we were also told that about Thalidomide, DES and Hormone Replacement Therapy. Negative health concerns have also been raised about other children’s vaccines and the Anthrax vaccine given to those in the armed forces as well as drugs like Vioxx, another Merck drug.

While Merck says that Gardasil is 100% effective in preventing the two types of the HPV virus that cause 70% of all cervical cancer, questions have arisen about these results. In an article in Healthfacts, Maryann Napoli, associate director of the Center for Medical Consumers reports that according to Barbara Loe Fisher, president of the National Vaccine Information Center and a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, the placebos in Merck’s studies contained aluminum (which is reported to cause inflammation and cell death in animals and humans) rather than saline solution, which according to Fisher “violates the principle of scientific method . . . making it hard to tell whether the many adverse events reported were due to the use of aluminum in both the placebo and the drug or to the Gardasil itself.

And in an essay published in the New York Times in July 2006, Roni Rabin points out that most of the subjects in the Merck trials were women over the age of 16. Rabin found that the vaccine was only tested on 1,200 girls under the age of 16. In addition, the vaccine is so new that it is not yet known for how long it will be effective or whether a booster will be required. It is also important to note that Merck’s own literature states that Gardasil, “has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”

It is not that guarding against HPV is not a good idea, in theory of course it is a great idea, but a healthy dose of skepticism is appropriate when it comes to believing the promises or stated motives of pharmaceutical companies. It seems unconscionable to mandate the use of a vaccine that has the potential to put the lives and health of an entire generation of girls at risk for the sake of preventing a cancer that is a risk to so few young women in this country and which can already be prevented by other less risky means.

"Matter of Vigorous Debate"

The history of America’s anti-vaccination movement, current vaccination concerns and Homer Simpson were the topics of discussion at Wednesday night’s university forum lecture.

Robert Johnston, a University of Illinois history professor and author of the book “The Radical Middle Class,” took to the podium at the auditorium in the Barrick Museum to challenge conventional wisdom about anti-vaccinationists, while evoking the knowledge of a very popular cartoon character.

“Tonight I’m going to call on Homer Simpson to begin the stories here,” Johnston said, with giggles bouncing throughout the audience.

He then described an episode of the Simpsons in which Homer discovered a vast conspiracy involving the flu vaccine and its heightening of the impulse to shop during the holiday season.

Johnston cited the episode, which aired in 2000, as an example of how vaccination fears have reemerged in the political spotlight in recent times.

Even timelier, said Johnson, is the controversy currently brewing in Texas, where Governor Rick Perry issued an executive order requiring all middle-school aged girls to receive a vaccine to protect them from the sexually transmitted Human Papoloma Virus.

“It’s something that is very much a matter of vigorous debate,” Johnston said, not going into detail about which side of the issue he stood on.

Other concerns over mandatory vaccinations have been felt by those involved with the military.

“We have a whole set of other issues including soldiers in the Iraq War refusing to get Anthrax vaccines,” he said. “The case against Anthrax vaccines seems to be strong.”He referenced the near closing of an Anthrax vaccine producer due to health concerns and questioned the quality of the vaccine the soldiers were being forced to take.

“The government itself is perfectly willing to admit that the Anthrax vaccine is a quite crude vaccine,” he said. “The question is whether military personnel should be unwilling subjects of a medical experiment.”

But understanding current controversies about vaccination is greatly increased by putting them in an historical context, Johnston said.

“There is a very long tradition of concern and skepticism and activism against vaccines,” he said. “It’s a kind of history that might be able to tell us how we might deal with these issues today.”

Although conventional wisdom often labels those opposed to vaccination as irrational and dangerous, Johnston argued their points were often “wise and insightful.”

“You can point to a figure like Gandhi who was a very strong anti-vaccinationist,” he said, adding that along with Gandhi, civil rights leader Frederick Douglass was also vigorously opposed to vaccinations.

Throughout American history, Johnston cited anti-vaccination as a long-practiced tradition. In fact it was so rampant that in 1913 the U.S. was declared the least vaccinated country in the industrial world.

“This was the land of liberty,” he said. “And in America you were to have control over your own body.”

As passionate as the movement was up until the beginning of the 20th century, it remained dormant until 1982.

It was that year when “Vaccine Roulette” was released, a documentary that worked to expose the danger faced by children who had been vaccinated for whooping cough. Middle-class parents became outraged, the government was criticized and the anti-vaccination movement had a new breath of life that would lead it to the Simpsons and the citizens of Texas.

But Texas hasn’t been the only state worried about forced vaccination. Nevada, partly due to its significant amount of Libertarian beliefs, has one of the lowest vaccination rates in the country.

As the lecture came to an end, a man in the audience offered a solution that would ease most concerns over the danger of vaccinations.

“I think we’d all probably jump on board and be a little easier if the first people to get the vaccines publicly injected it,” he said. “They would be the President, the Vice President and members of Congress.”